Dr. Gartland 
page 2 
Tab C - Page 2 
April 24, 1985 
orgaaiam has been accomplished previously using techniques other than recom- 
binant DMA, and deletion mutants have been demonstrated to occur naturally. 
Therefore, the organism produced by recombinant DNA deletion cannot be con- 
sidered unique; and 3) Since the test organism does not contain a foreign gene 
and is not unique, it poses little or no added risk than that experienced under 
what are considered natural conditions. 
The EA makes a convincing case for the need for the proposed field test. We are 
certainly persuaded that the benefit of using ice-nucleation-minus bacteria will 
justify any risk that may be involved. Alternative procedures for protecting 
plants against frost damage require large amounts of energy and water or consume 
large quantities of fossil fuels, and they can create health hazards and adver- 
sely affect environmental quality. The Berkeley case offers certain benefits 
and limited risk, if any risk at all. 
The Need for & Programmatic Environmental Impact S tatement 
We question whether an EIS is desirable or necessary in the specific case of the 
experiment by Drs. Lindow and Panopoulos to test ice-nucleation-minus bacteria 
prepared by recombinant-DNA techniques. We also question whether a programmatic 
EIS should be required in any case where an adequate EA is provided. By defini- 
tion, a programmatic EIS is concerned with broad issues rather than with speci- 
fic considerations which relate to a particular site. In the Berkeley case, and 
it seems to us in all but the most unusual circumstance, an EA will serve as 
well as an EIS to identify environmental effects. The EA is more concerned than 
the EIS with the present. The EIS is more forward-looking than the EA, and the 
availability of an EA without an EIS will not necessarily obstruct environmental 
review. The absence of a programmatic EIS does pot hinder a continuing concern 
for environmental effects. 
The thoroughness of preparation of the EA and the fact that the organism to 
be tested by the Berkeley scientists does not contain a foreign gene and is not 
unique, obviates the need in this case for a programmatic EIS. If future EAs 
are as thoroughly and well prepared as the present document, there should be 
little need in general for programmatic EISs. Nevertheless, any experiment 
which proposes to take an organism from the laboratory and apply it in the field 
must undergo careful review, and the need for that review must be determined on 
a case-by-case basis. Given an EA, the decision concerning need for a program- 
matic EIS also should be made on a case-by-case basis. Every effort should be 
made to see that a programmatic EIS is not required if all it accomplishes is to 
duplicate what is already presented in, an EA. 
The PSA2 applauds the NIH and the NIH Recombinant DNA Advisory Committee (SAC) 
for the way they have managed a difficult assignment very well. In conclusion, 
we believe that NIH has effectively dealt with this issue and that there is no 
further need for a programmatic Environmental Impact Statement. The NIH has 
acted cautiously while at the same time untold financial damage was incurred 
this past year in Florida. In spite of a careful and cautious review of all 
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